An Exploratory Trial Investigating the Neurogenic Component in Psoriasis Vulgaris by Use of Botulinum Toxin A

NCT02577185 | Completed Phase 1

• 1 other identifier: EXP-1187
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the anti-psoriatic effect of injected Botulinum toxin type A compared to that of injected vehicle.

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

• Absolute change in Total Clinical Score (TCS) of clinical signs at 8 weeks after injection compared to baseline

  8 weeks

Secondary Outcomes (20)

• Absolute change in clinical score erythema at week 1 compared to baseline

  1 week

• Absolute change in clinical score erythema at week 3 compared to baseline

  3 weeks

• Absolute change in clinical score erythema at week 4 compared to baseline

  4 weeks

• Absolute change in clinical score erythema at week 8 compared to baseline

  8 weeks

• Absolute change in clinical score scaling at week 1 compared to baseline

  1 week

Study Arms (2)

botulinum toxin type A

EXPERIMENTAL

Experimental drug

Drug: Botulinum Toxin Type A

sodium chloride 9 mg/ml

PLACEBO COMPARATOR

Vehicle drug

Drug: Sodium chloride 9 mg/ml

Interventions

Botulinum Toxin Type A DRUG

botulinum toxin type A

Sodium chloride 9 mg/ml DRUG

sodium chloride 9 mg/ml

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or above
• A diagnosis of psoriasis vulgaris with lesions located on arms and/or legs and/or trunk
• Chronic stable psoriasis vulgaris diagnosed more than 6 months prior to screening.
• Women must use a reliable contraceptive during the trial.

You may not qualify if:

• Pregnant or breast feeding women, or women planning to become pregnant.
• Skin infection at injection sites
• Use of biological therapies or small molecules (marketed or not marketed) with a possible effect on psoriasis vulgaris
• Use of systemic treatments with a potential effect on psoriasis vulgaris
• Exposure to phototherapy within 4 weeks for PUVA and 2 weeks for UVB prior to Randomisation
• Use of potent or very potent (WHO group III-IV) corticosteroids for topical treatment of psoriasis within a 4 week period prior to randomisation
• Use of muscle relaxants
• History of dysphagia or aspiration
• Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (2)

Hud- og Kønssygdomme, Aarhus Universitetshospital

Aarhus, 8000, Denmark

Location

Hud- og allergiafdeling, Gentofte Hospital

Gentofte Municipality, 2900, Denmark

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A; Sodium Chloride

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Lars Iversen, MD

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2015
• First Posted: October 16, 2015
• Study Start: November 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: February 24, 2025

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)